Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centros de Investigación de Nutrición y Salud | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a pilot, proof-of-concept, exploratory, randomized, double-blind, placebo-controlled crossover study. The study will be conducted in 50 healthy volunteers with a body mass index (BMI) between 18.5 and 29.9 kg/m². The objective is to comprehensively evaluate the potential of DNF-10 to modulate appetite through the regulation of enteroendocrine hormones and to determine its relevance in human physiology.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | DNF-10 |
|
| Control | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNF-10: 250 mg/day | Dietary Supplement | DNF-10 |
| |
| Placebo: 250 mg maltodextrin/day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with dysfunctional eating behavior | The primary objective of the study is to evaluate the effect of DNF-10 on dysfunctional eating behavior in the study population compared with placebo, specifically on the frequency of:
| Baseline and after 1 month of treatment in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of food intake in response to emotional states | Baseline and after 1 month of treatment in each treatment period | |
| Concentration of entero-hormone biomarkers | Baseline and after 1 month of treatment in each treatment period |
Not provided
Inclusion Criteria:
Healthy men and women aged 20 to 50 years.
Body Mass Index (BMI) of 18.5-24.9 kg/m² or 25.0-29.9 kg/m².
Stable use of permitted medications and/or dietary supplements during the study.
Individuals willing to maintain their usual dietary and physical activity habits throughout the study.
Subjects capable of understanding and complying with the study procedures.
Subjects who have signed the informed consent form.
Female participants must meet one of the following conditions:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | Madrid | 28050 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Placebo |
|
| Weight in kilograms | Baseline and after 1 month of treatment in each treatment period |
| Waist circumference in centimeters | Baseline and after 1 month of treatment in each treatment period |